From et al.

BMC Public Health 2013, 13:125

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STUDY PROTOCOL Open Access

Effectiveness of exercise intervention and health

promotion on cardiovascular risk factors in
middle-aged men: a protocol of a randomized
controlled trial
Svetlana From1*, Helena Liira1, Jenni Leppävuori2, Taina Remes-Lyly3, Heikki Tikkanen2 and Kaisu Pitkälä1

Abstract
Background: Although cardiovascular disease has decreased, there is still potential for prevention as obesity and
diabetes increase. Exercise has a positive effect on many cardiovascular risk factors, and it can significantly reduce
the components of metabolic syndrome. The main challenge with exercise in primary care is how to succeed in
motivating the patients at risk to change and increase their exercise habits. The objective of this study is to modify
the cardiovascular risk in middle-aged men, either through a health promotion intervention alone or combined
with an exercise intervention.
Methods/design: During a two-year period we recruit 300 men aged from 35 to 45 years with elevated
cardiovascular risk (> two traditional risk factors). The men are randomized into three arms: 1) a health promotion
intervention alone, 2) both health promotion and exercise intervention, or 3) control with usual community care
and delayed health promotion (these men receive the intervention after one year). The main outcome measures
will be the existence of metabolic syndrome and physical activity frequency (times per week). The participants are
assessed at baseline, and at 3, 6, and 12 months. The follow-up of the study will last 12 months.
Discussion: This pragmatic trial in primary health care aimed to assess the effect of a health promotion
programme with or without exercise intervention on cardiovascular risk and physical activity in middle-aged men.
The results of this study may help to plan the primary care interventions to further reduce cardiovascular mortality.
The study was registered at the Controlled Trials (www.controlled.trials.com). Trial number: ISRCTN80672011. The
study received ethics approval from the Coordinating Ethics Committee at Helsinki University Hospital on 8 June
2009 (ref: 4/13/03/00/09).
Keywords: Exercise intervention, Health promotion, Metabolic syndrome, Exercise activity

Background combination with other lifestyle changes and treatments

Cardiovascular diseases continue to be among the most im-
portant causes of mortality, especially in men. In Finland,
the North Karelia project is a success story of effective
health promotion to reduce cardiovascular risk [1]. From a
public health perspective, exercise is one the most effective
means of reducing the risk of cardiovascular diseases.
Exercise is a key modifiable factor either alone or in
* Correspondence: svetlana.from@helsinki.fi
1
Helsinki University Central Hospital, Unit of Primary Health Care and
University of Helsinki, Department of General Practice and Primary Health
Care, Helsinki, Finland
Full list of author information is available at the end of the article
to reduce hypertension and elevated cholesterol levels.
The effectiveness of exercise has been shown in weight
loss [2], particularly when combined with dietary changes.
Exercise also decreases the incidence of type 2 diabetes
mellitus in high risk groups (people with impaired glucose
tolerance or the metabolic syndrome) [3]. There is also
evidence that exercise improves the metabolic syndrome
in general [4] and reduces HbA1c levels in patients with
type 2 diabetes [5].
There is a lot of interest in cardiovascular risk reduc-
tion in primary care and many interventions are nurse-

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From et al. BMC Public Health 2013, 13:125
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based [6,7]. Many communities in Finland have recently
adopted health examinations by public health nurses for
40-year-old men to improve their lifestyle habits. Al-
though the effectiveness of such interventions may now
be questionable [8], at the planning stage of this project
it was essential to include a nurse-based intervention. At
the Kirkkonummi Health Center, we decided to combine
a randomized controlled trial at the onset of such a
health promotion project. The trial was approved by the
municipality authorities.
A major challenge in health behavior changes is the
maintenance of the adopted lifestyle [9]. An individual
approach may not be sufficient for change. A group-
based exercise intervention may motivate the participants
to continue with their new exercise habits [10]. In addition
to the health promotion intervention by a nurse, we
included a group exercise intervention to increase the
effectiveness of the intervention.
We aimed to develop an exercise intervention model
for primary care that increases the physical activity of
middle-aged men with increased cardiovascular risk. A
randomized controlled trial was carried out to study the
effects of this intervention. We also aimed to establish
cooperation between a health center and other municipal
activities, namely adult education and exercise services in
health promotion of middle-aged men. The aim of this
randomized controlled trial is to investigate the effects of
this intervention on participants’ metabolic syndrome and
physical activity.
Objectives
The main aim of the study is to assess the effect of the
interventions on physical activity and metabolic syn-
drome in middle-aged men, having at least two cardio-
vascular risk factors at the beginning of the trial.
The effect of the intervention on the individual risk
factors of metabolic syndrome (overweight, waist circum-
ference, blood cholesterol level, high-sensitivity C-reactive
protein (hs-CRP)), on the physical activity factors (self-
reported physical activity, and 2 km walking test), and body
constitution as measured by InBodyW are also examined.
Methods/design
Study design
The study is a three-arm one-center randomized con-
trolled trial (Figure 1). Two methods of health promotion
are studied in middle-aged men with elevated cardiovascu-
lar risk. After screening and randomization, one study
group receives a 1½-hour health promotion intervention
by a public health nurse. The other intervention group
receives, in addition to public health nurse intervention,
a guided group exercise intervention of 12 weeks. The
third group is randomized to serve as a control and men
Page 2 of 5
in this group may participate in the intervention after
one year, should they wish to.
Ethics approval
The study received ethics approval from the Coordinating
Ethics Committee at Helsinki University Hospital on 8
June 2009 (ref: 4/13/03/00/09). All participants receive
both oral and written participant information and are
asked to give written informed consent.
Recruitment and time schedule
We recruite men aged 35 to 45 years with at least two car-
diovascular risk factors. They are recruited to the project
in three ways: 1) by invitation letter to the 40-year-old age
cohort, 2) by identifying high-risk group of men within
health services (targeted opportunistic screening), and 3)
by informing about the project in the media and on the
Internet.
The study protocol was accepted in 2009 and recruit-
ment of study subjects and randomization started in
2010.
Inclusion criteria
▪ Age 35–45 years
▪ At least two cardiovascular risk factors as follows:
- BMI 27–34 kg/m2
- Waist circumference > 94 cm
- Fasting glucose >6.1 mmol/l
- Total plasma cholesterol >4.0 mmol/l
- LDL-cholesterol > 3.0 mmol/l
- Triglycerides >2.0 mmol/l
- Systolic blood pressure > 140 mmHg
- Diastolic blood pressure > 90 mmHg
- Currently either :
 Smoking
 On cholesterol-lowering medication
 On blood pressure-lowering medication
Exclusion criteria
– BMI over 34 (or any other physical barrier
preventing participation in the exercise intervention)
– Active exerciser (exercising at least 30 minutes 3
times a week or more)
– Having an immediate health problem requiring
treatment or a severe risk factor; for example,
recently diagnosed or uncontrolled type I diabetes,
or a symptomatic coronary artery disease.
Study interventions
In addition to study interventions, all groups receive, if
necessary, standard treatment at Kirkkonummi Health
Center, a municipal public primary care unit. If a
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Screening/recruitment

Enrollment Excluded

Laboratory

Randomized (n= 300)

Allocation

A. Health promotion by B. Health promotion by a

public health nurse public health nurse and C. Control group
(n= 100) exercise intervention (n = 100)
(n = 100)
Follow-Up

Follow up 3,6 and 12 Follow up 3,6 and 12 Follow up 3,6 and 12

month month month

Analysis Analysis Analysis

Analysis

Figure 1 Study design and flow chart.

participant shows any need of medical treatment, or his Exercise intervention

medications required medical attention, he is referred
to a primary care physician.
Health promotion intervention by nurse
Public health nurses use standard practices in their health
promotion intervention. Before onset of the trial they re-
ceive education from the Finnish Heart Association. The
nurses use the type 2 diabetes disease risk assessment form
(Finnish Diabetes Association), and cardiovascular risk as-
sessment (the Finnish Heart Association). The intervention
includes assessment of individual risks, dietary habits, phys-
ical activity and a motivational talk about the habits. The
intervention lasts up to 90 minutes and does not include
follow-up.
If the men have elevated blood sugar, total plasma
cholesterol over 7.0 mmol/l, uncontrolled hyperten-
sion or another reason for medical assessment, the
nurse referres the patient to a physician for consider-
ation of medication.
In addition to the health promotion intervention, the
other group is invited to a group exercise intervention.
The size of the teaching groups is from 10 to 20 people.
The exercise intervention is guided by a physical educa-
tion counselor and consists of basic physical training. The
exercise sessions each last 60 minutes. During the 12
weekly meetings several safe and moderately strenuous
exercise activities are carried out, such as Nordic walking,
fitness circle, volleyball, swimming, circuit training, gym,
boxing, zumba, etc.
The exercise intervention aims at creating a comfort-
able atmosphere that encourages safe and regular phys-
ical training. Another aim is form groups of men that
might continue exercising together.
Control group
The participants of the control group receive both the
health examination and the exercise intervention after
the 12-month follow-up, if they so wish.
From et al. BMC Public Health 2013, 13:125
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Outcome measures
The outcomes are measured after 3, 6 and 12 months of
the randomization. The blood tests are taken at months
0, 3 and 12. Other outcomes are measured by Internet
surveys and, if the participant does not respond, by tele-
phone surveys.
Primary outcome measures will be 1) metabolic syn-
drome defined by International Diabetes Federation/
American Heart Association [11], thus fulfilling three or
more of the following criteria:
- systolic blood pressure ≥ 130 or diastolic blood
pressure ≥ 85 or specific medication;
- triglyserides ≥1.7 mmol/L or specific medication;
- HDL cholesterol < 1.0 mmol/L or specific medication
- fasting plasma glucose ≥ 5.6 mmol/L or specific
medication;
- waist circumference >94 cm
2) and self-reported physical activity measured by how
many times per week a participant performs vigorous
exercise activity. Table 1 shows also the secondary out-
come measures.
Randomization
Once the men have consented to participate in the study
and the baseline measurements are carried out, they are
randomly allocated to one of the three study groups. A
randomization list based on random numbers is made and
transferred to sequentially numbered sealed envelopes.
Table 1 Outcome measures
Variable
1. Primary outcome measures
1.1 Metabolic syndrome1 (yes/no)
● Blood pressure, waist circumference,
● Blood LDL- and HDL-cholesterol, triglycerides,
blood glucose
1.2 Physical activity
● Self-reported physical activity, exercise times,
per week
2. Other outcome measures
● 2 km walking test (s)
● Self-reported general health (0–100)
● Self-reported overall stress (0–100)
● Utilisation and costs of medical services
● Individual cardiovascular risk factors: total
cholesterol (mmol/L), LDL-cholesterol (mmol/L),
HDL-cholesterol (mmol/L), smoking (yes/no),
blood glucose (mmol/L), hs-CRP (mmol/L)
● Body composition (InBody): muscle mass (kg),
body fat mass (kg)
1 Defined by International Diabetes Federation/American Heart Association [11].
Page 4 of 5
Sample size
Sample sizes were calculated by statistical power ana-
lysis. We hypothesised that the percentage of men con-
tinuing the increased exercise level after one year would
be 30% in the control group and 50% in the exercise
group. To detect this difference with α = .05 and β = .80,
91 men in each group are needed.
Statistical analysis
A primary intention-to-treat analysis will be carried out.
The main analyses involve standard two-sample compar-
isons (parametric or non-parametric depending on the
distribution of the data) looking at effect sizes at 3 and
12 months.
Qualitative analysis
In addition to quantitative methods, focus group discus-
sions are conducted in order to study the experiences of
the men in the intervention, the acceptability of the inter-
vention and the barriers and facilitators for lifestyle change
in men. The focus group discussions are held after the
execution of the intervention. Using a qualitative approach
we also study what the men’s experiences of the group ex-
ercise intervention are and whether they continue these
activities after the trial. Also, the men’s preferred methods
for joining projects aiming at lifestyle changes and other
societal aspects are examined.
Discussion
In this study, we assess the effects of primary care
interventions aiming to reduce cardiovascular risk in
early middle-aged men. Health promotion by public
T0 T1 T2 T3 health nurses has become a popular method in cardio-
vascular prevention. Its effectiveness has, however, re-
cently been questioned [4]. At the onset of this the trial,
x x x x
it was clear that it had to be included it in the interven-
tion. We also wanted to study an exercise intervention,
as many cardiovascular risk factors can be controlled
through exercise [12,13].
x x x x We chose a group-based intervention because we
considered the social support in the group to be an
important motivational factor for the success of the
intervention. Kirkkonummi is a suburban municipality,
x x x where most of the families move from other parts of
x x x x Finland to work in the capital region. Many men do not
x x x x
have the social networks of their youth for maintaining
their exercise activities. One possible result of this trial is
x x x x
that men continue to exercise in their intervention groups.
x x x x We will follow-up for the potential societal effects of the
x x x trial using qualitative methods.
The strengths of this study are that it is a primary
x x x care pragmatic trial and that the results are readily
generalizable to similar primary care settings. Also, the
interventions included are feasible and non-expensive.
From et al. BMC Public Health 2013, 13:125
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If they prove effective, they can easily be transferred to
other similar circumstances.
The study has some limitations as well. Blinding is not
feasible and this study is performed as an open trial.
Randomized controlled trials are not common in pri-
mary care health centers and there are threats to validity,
e.g. how to guarantee similar processes by all study
nurses and how to avoid other protocol violations. A
special challenge is to keep the participants in the con-
trol group. As the participating men are not patients but
working-aged and busy, their participation in the out-
come measurements is a challenge.
The results of this study assess the effects of the
interventions on physical activity and cardiovascular risk.
We chose physical activity as a main outcome because
from earlier literature we know that if men continue on
their increased physical activity level, they will gain health
benefits. The cardiovascular risk is a surrogate endpoint. It
would, however, not be feasible to study morbidity because
onset of cardiovascular risk will take years or decades in
these men. In addition to these quantitative outcomes,
assessing the participants’ views on barriers and facilitators
to lifestyle changes after their experiences in the trial in
the qualitative analysis will be of importance.
This study will provide information on the effects of an
exercise intervention on cardiovascular risk and physical
activity in middle-aged men. This pragmatic trial will shed
light on the success of a physical activity intervention in
real life, which is a recognized challenge in studies aiming
at metabolic disease control [14]. The results of this study
can be used in the planning of interventions aimed at
reducing cardiovascular risk, diseases and mortality in
primary care.
Competing interests
Dr Pitkälä reports having professional cooperation including lecturing fees
from pharmaceutical and other health care companies (including Lundbeck,
MSD Finland, Novartis, Nestle), and having participated in clinical trials
funded by pharmaceutical companies. Dr Liira has participated in Advisory
Boards of Phizer and given lectures for Phizer and Abbott. Other authors
declare no competing interests.
Authors’ contributions
This study was carried out at the Kirkkonummi Health Center. Conception and
design (HL, JL, TR-L, HT, KP), acquisition of data, or analysis and interpretation of
data (SF, HL, JL, TR-L, HT, KP), drafting or critically revising the manuscript for
important intellectual content (SF, HL, JL, TR-L, HT, KP); approval of the final
manuscript (SF, HL, JL, TR-L, HT, KP KHP). KHP is the guarantor.
Acknowledgements
We are grateful for the participating Kirkkonummi community staff and men
for their enthusiastic participation in this study. We wish to thank public
health nurse Mona Svartström for co-operation and help with the study, as
well as exercise counselors Anni Henriksson and Maria Holm.
Author details
1 Cite this article as: From et al.: Effectiveness of exercise intervention
Helsinki University Central Hospital, Unit of Primary Health Care and
University of Helsinki, Department of General Practice and Primary Health
Care, Helsinki, Finland. 2Department of Sports and Exercise Medicine,
University of Helsinki and Foundation of Sports and Exercise Medicine,
Helsinki, Finland. 3Kirkkonummi Health Center, Kirkkonummi, Finland.
Page 5 of 5
Received: 31 October 2012 Accepted: 4 February 2013
Published: 11 February 2013
References
1. Pietinen P, Lahti-Koski M, Vartiainen E, Puska P: Nutrition and
cardiovascular disease in Finland since the early 1970s: A success story.
J Nutr 2001, 5(3):150–4.
2. Shaw KA, Gennat HC, O'Rourke P, Del Mar C: Exercise for overweight or
obesity. Cochrane Database Syst Rev 2006, (4):CD003817. doi:10.1002/
14651858.CD003817.pub3.
3. Orozco LJ, Buchleitner AM, Gimenez-Perez G, Roquéi Figuls M, Richter B,
Mauricio D: Exercise or exercise and diet for preventing type 2 diabetes
mellitus. Cochrane Database Syst Rev 2008, (3):CD003054. doi:10.1002/
14651858.CD003054.pub3.
4. Johnson JL, Slentz CA, Houmard JA, et al: Exercise training amount and
intensity effects on metabolic syndrome (from Studies of a Targeted Risk
Reduction Intervention through Defined Exercise). Am J Cardiol 2007,
100:1759–66.
5. Umpierre D, Ribeiro PA, Kramer CK, Leitão CB, Zucatti AT, Azevedo MJ, Gross
JL, Ribeiro JP, Schaan BD: Physical activity advice only or structured
exercise training and association with HbA1c levels in type 2 diabetes: a
systematic review and meta-analysis. JAMA 2011, 305(17):1790–9.
6. Wood DA, Kotseva K, Connolly S, Jennings C, Mead A, Jones J, Holden A, De
Bacquer D, Collier T, De Backer G, Faergeman O, EUROACTION Study Group:
Nurse-coordinated multidisciplinary, family-based cardiovascular disease
prevention programme (EUROACTION) for patients with coronary heart
disease and asymptomatic individuals at high risk of cardiovascular
disease: a paired, cluster-randomised controlled trial. Lancet 2008,
371(9629):1999–2012.
7. Ebrahim S, Taylor F, Ward K, Beswick A, Burke M, Davey Smith G: Multiple
risk factor interventions for primary prevention of coronary heart
disease. Cochrane Database Syst Rev 2011, (1):CD001561.
8. Koelewijn-van Loon MS, van der Weijden T, van Steenkiste B, Ronda G,
Winkens B, Severens JL, Wensing M, Elwyn G, Grol R: Involving patients in
cardiovascular risk management with nurse-led clinics: a cluster
randomized controlled trial. CMAJ 2009, 181(12):E267–74.
9. Fleming P, Godwin M: Lifestyle interventions in primary care: systematic
review of randomized controlled trials. Can Fam Physician 2008, 54:1706–13.
10. Laatikainen T, Dunbar JA, Chapman A, et al: Prevention of type 2 diabetes
by lifestyle intervention in an Australian primary health care setting:
Greater Green Triangle (GGT) Diabetes Prevention Project. BMC Publ
Health 2007, 7:249.
11. Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA,
Fruchart JC, James WP, Loria CM, Smith SC Jr, International Diabetes
Federation Task Force on Epidemiology and Prevention; National Heart,
Lung, and Blood Institute; American Heart Association; World Heart
Federation; International Atherosclerosis Society; International Association
for the Study of Obesity: Harmonizing the metabolic syndrome: a joint
interim statement of the International Diabetes Federation Task Force
on Epidemiology and Prevention; National Heart, Lung, and Blood
Institute; American Heart Association; World Heart Federation;
International Atherosclerosis Society; and International Association for
the Study of Obesity. Circulation 2009, 120(16):1640–5.
12. Eriksson MK, Franks PW, Eliasson M: A 3-year randomized trial of lifestyle
intervention for cardiovascular risk reduction in the primary care setting:
the Swedish Bjorknas study. PLoS One 2009, 4(4):e5195.
13. Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-
Parikka P, et al: Prevention of type 2 diabetes mellitus by changes in
lifestyle among subjects with impaired glucose tolerance. N Engl J Med
2001, 344(18):1343–50.
14. Linmans JJ, Spigt MG, Deneer L, Lucas AE, de Bakker M, Gidding LG, Linssen
R, Knottnerus JA: Effect of lifestyle intervention for people with diabetes
or prediabetes in real-world primary care: propensity score analysis. BMC
Fam Pract 2011, 12:95.
doi:10.1186/1471-2458-13-125
and health promotion on cardiovascular risk factors in middle-aged
men: a protocol of a randomized controlled trial. BMC Public Health 2013
13:125.
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